Drugs

J&J Imaavy sBLA for Rare Anemia Gets Priority Review

FDA has accepted for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemolytic anemia (wAIHA). The rare, potentially life-threatening disorder is caused by immunoglobulin G (IgG ) autoantibodies that target and destroy red blood cells, leading to anemia, the company says. There are currently no FDA-approved therapies specifically indicated for treatment.

The submission is based on data from the Phase 2/3 ENERGY trial, a randomized, double-blind, placebo-controlled study in adults with wAIHA. According to the company, a greater proportion of patients treated with nipocalimab achieved a durable hemoglobin response — defined as hemoglobin levels of at least 10 g/dL with an increase of at least 2 g/dL from baseline sustained for 28 days — compared with placebo. Patients receiving the therapy also reported improvements in fatigue, a key symptom of the disease.

The company says Imaavy is designed to block the neonatal Fc receptor, reducing circulating IgG antibodies — including pathogenic autoantibodies — while preserving other immune functions. By targeting the underlying mechanism of disease, the therapy represents a more selective approach compared with existing immunosuppressive treatments.

Nipocalimab is already approved in the U.S. for generalized myasthenia gravis in certain adult and pediatric patients and is being studied across multiple auto- and alloantibody-driven conditions, including rare autoimmune and maternal-fetal diseases.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome